FDA Inspection
Graphic Controls Acquisition CorporationGraphic Controls Acquisition Corporation – FDA Inspection, May 14, 2018
Record Details
This FDA Inspection record concerns Graphic Controls Acquisition Corporation, with an inspection on May 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · edfbc7e1-5d61-4645-be75-669d616f1b88
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051938
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Graphic Controls Acquisition Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 5, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Graphic Controls Acquisition Corporation
- FDA Inspection 1135942 - 2021-02-23
- FDA Inspection 1040302 - 2018-01-26
- FDA Inspection 905863 - 2014-12-05
- FDA Inspection 883433 - 2014-06-11
- FDA Inspection 845536 - 2013-08-22
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